CN117915977A

CN117915977A - Prolonged guide catheter

Info

Publication number: CN117915977A
Application number: CN202280060341.0A
Authority: CN
Inventors: 加藤知也
Original assignee: Kaneka Corp
Current assignee: Kaneka Corp
Priority date: 2021-10-14
Filing date: 2022-09-08
Publication date: 2024-04-19
Also published as: WO2023062985A1

Abstract

An elongate guide catheter (1) for a guide catheter, comprising: a cylindrical body (2) having an inner cavity (3) extending in the longitudinal direction; and a linear member (12) extending from the tubular body (2) to the proximal side, wherein an annular or spiral groove portion extending in the circumferential direction is provided on the inner side surface of the distal end portion (6) of the tubular body (2), and the thickness of the tubular body (2) is formed to be thin at the portion where the groove portion is provided.

Description

Prolonged guide catheter

Technical Field

The present invention relates to an extension guide catheter for a guide catheter, and more particularly, to an extension guide catheter which is inserted into a guide catheter and is used by extending and protruding from an opening on a distal side of the guide catheter.

Background

Percutaneous transluminal coronary angioplasty (PCI) is performed for ischemic heart diseases such as stenoses and myocardial infarction, and uses an intravascular treatment device such as a stent or balloon to dilate a stenosed portion of a coronary artery of the heart, thereby increasing blood flow. In this case, the distal end of the tubular guide catheter is usually inserted into the inlet of the coronary artery and placed therein, and then the intravascular treatment device is delivered through the guide catheter, whereby the insertion of the intravascular treatment device into the distal end of the coronary artery is improved. However, when the supporting force is small and the indwelling is unstable, the distal end of the guide catheter may be detached from the inlet of the coronary artery. In this case, an extension guide catheter having a smaller diameter than the guide catheter may be inserted into the guide catheter and the extension guide catheter may be extended from the distal opening of the guide catheter to increase the supporting force.

Various such elongate guide catheters are known. For example, patent document 1 discloses a guide extension guide catheter having a proximal member including an extension portion, a collar member attached to the extension portion, and a distal sheath member attached to the collar member. Patent document 2 discloses a guide extension catheter including a pressing member having a portion including a first surface formed with a groove and a second surface opposite to the first surface, and a distal shaft adjacent to the pressing member and having a passage. Patent document 3 discloses an extension duct including a cylindrical portion, a first tapered portion located closer to the cylindrical portion than the first tapered portion, and a second tapered portion located closer to the cylindrical portion than the first tapered portion, wherein an angle formed between a first tapered surface of the first tapered portion and an axial direction of the cylindrical portion is 90 ° to 145 °, and an angle formed between a second tapered surface of the second tapered portion and the axial direction of the cylindrical portion is 120 ° to 175 °.

Patent document 1: international publication No. 2018/075700

Patent document 2: international publication No. 2017/214209

Patent document 3: international publication No. 2020/162286

The extension guide catheter is inserted into the guide catheter and used, but when a treatment device such as an intravascular treatment device is sent out from the guide catheter through the extension guide catheter, the distal end of the extension guide catheter may be located at the curved portion of the body cavity. In this case, there is a concern that the distal end portion of the extension guide catheter is bent at the bent portion of the body cavity, and the cross-sectional shape of the lumen is greatly deformed, with the result that there is a concern that: treatment devices such as intravascular treatment devices are difficult to smoothly pass through the distal end portion of the extension guide catheter, and thus, it is difficult to extend and protrude the treatment devices from the distal opening of the extension guide catheter. The present invention has been made in view of the above-described circumstances, and an object thereof is to provide an extension guide catheter capable of suppressing a cross-sectional shape of a lumen from being greatly deformed at a distal end portion of the extension guide catheter even if the distal end portion is bent.

Disclosure of Invention

The elongate guiding catheter of the present invention is described below.

[1] An elongate guide catheter for a guide catheter, comprising: a tubular body having an inner cavity extending in a longitudinal direction and having a proximal opening and a distal opening; and a linear member fixed to the tubular body, extending from a proximal opening of the tubular body to a proximal side, wherein an annular or spiral groove portion extending in a circumferential direction is provided on an inner side surface of a distal end of the tubular body, and a wall thickness of the tubular body is formed to be thin at a portion where the groove portion is provided.

Since the distal end portion of the tubular body is formed as described above, the distal end portion of the extension guide catheter of the present invention is easily bendable and smoothly moves in the guide catheter and the body cavity. In addition, even if the distal end portion of the tubular body is located at the curved portion of the body cavity, kink (king) is not likely to occur in the distal end portion of the tubular body, and the cross-sectional shape of the lumen is suppressed from being greatly deformed in this portion. Therefore, it is easy to extend and protrude a treatment device such as an intravascular treatment device from the distal opening through the distal end of the tubular body.

[2] The extension guide catheter according to item [1], wherein the outer surface of the distal end of the tubular body is formed flat in the longitudinal direction in which the groove is provided.

When the distal end portion of the tubular body is formed as described above, the distal end portion of the tubular body does not catch on the inner wall of the guide catheter or the body cavity when the extension guide catheter is advanced in the guide catheter, and the extension guide catheter can easily be advanced smoothly in the guide catheter or the body cavity.

[3] The extension guide catheter according to [1] or [2], wherein an outer surface of the distal end of the tubular body has an inclined portion that is inclined toward the long axis side of the tubular body.

As described above, if the inclined portion is formed on the outer surface of the distal end portion of the tubular body, the distal end portion of the tubular body can easily smoothly travel in the guide catheter and the body cavity, and the distal end portion of the tubular body can easily smoothly bend and travel in the bent portion of the guide catheter and the body cavity.

[4] The extension guide catheter according to any one of [1] to [3], wherein the distal end of the tubular body has a first section including the distal end of the tubular body and a second section closer to the distal end than the first section with respect to the longitudinal direction, and an outer surface of the distal end of the tubular body is formed parallel to the longitudinal direction in the second section, and the first section is formed inclined toward the longitudinal side of the tubular body in the distal direction.

[5] The extension guide catheter according to any one of [1] to [3], wherein the distal end of the tubular body has a first section including a distal end of the tubular body and a second section located closer to the distal end than the first section with respect to the longitudinal axis, and an outer surface of the distal end of the tubular body is formed to be inclined toward the longitudinal axis of the tubular body in the second section, and is formed to be inclined toward the longitudinal axis of the tubular body in the distal direction so that an angle formed between the outer surface and the longitudinal axis is larger than an angle formed between the outer surface and the longitudinal axis in the second section in the first section.

If the distal end portion of the tubular body is formed as described above, the distal end portion of the tubular body can easily smoothly travel in the guide catheter and the body cavity, and the distal end portion of the tubular body can easily bend and travel in the bent portion of the guide catheter and the body cavity.

[6] The extension guide catheter according to [4] or [5], wherein in the first section, an angle formed between the outer surface and the longitudinal direction becomes gradually or continuously larger toward the distal side.

If the distal end portion of the tubular body is formed as described above, the distal end portion of the tubular body can easily smoothly travel in the guide catheter or the body cavity.

[7] The extension guide catheter according to any one of [4] to [6], wherein the groove portion is provided in the second section.

If the groove portion is provided as described above, a deeper groove can be formed in the distal end portion of the tubular body.

[8] The extension guide catheter according to any one of [1] to [7], wherein the tubular body has a high-rigidity portion on a position side with respect to the longitudinal axis direction than the distal end portion, and the high-rigidity portion is made of a material having higher rigidity than the distal end portion.

If the tubular body is configured as described above, the tubular body can easily smoothly travel in the curved portion of the guide catheter or the body cavity.

[9] The extension guide catheter according to [8], wherein the distal end portion is composed of a resin layer, and the high-rigidity portion is composed of a resin layer and a spiral, mesh or braid-shaped reinforcing layer.

If the distal end portion of the tubular body is formed as described above, the inner cavity of the tubular body is less likely to be deformed by pressure in the high-rigidity portion, and kink is less likely to occur. In addition, it is easy to insert the treatment device into the lumen of the tubular body.

[10] The extension guide catheter according to any one of [1] to [9], wherein the distal end portion has an inner layer and an outer layer, the inner layer is made of a material having higher rigidity than the outer layer, and the groove portion is formed at least in the inner layer.

If the distal end portion of the tubular body is configured as described above, kink is less likely to occur at the distal end portion of the tubular body, and flexibility of the distal end portion of the tubular body is more likely to be ensured.

[11] The extension guide catheter of any one of [1] to [10], wherein the length of the distal end in the longitudinal direction is 1mm or more and 10mm or less.

In the extension guide catheter of the present invention, since the inner surface of the distal end portion of the tubular body is provided with the annular or spiral groove portion extending in the circumferential direction, the wall thickness of the tubular body is formed thin at the portion where the groove portion is provided, and therefore, the extension guide catheter is easy to smoothly travel in the guide catheter and the body cavity, and even if the distal end portion of the tubular body is located at the curved portion of the body cavity, kinks are not easy to occur at the distal end portion of the tubular body. The cross-sectional shape of the lumen is less likely to be greatly deformed at that portion. Therefore, it is easy to extend and protrude a treatment device such as an intravascular treatment device from the distal opening through the distal end of the tubular body.

Drawings

Fig. 1 is a view showing an entire extension guide catheter according to an embodiment of the present invention.

Fig. 2 is a view showing a state in which an elongate guide catheter according to an embodiment of the present invention is inserted into a guide catheter disposed in a blood vessel and is extended and projected from an opening on the distal side of the guide catheter.

Fig. 3 shows an example of a cross-sectional view of a distal end portion of an elongate guiding catheter according to an embodiment of the present invention along the longitudinal direction.

Fig. 4 shows another example of a cross-sectional view of the distal end of the elongate guiding catheter according to the embodiment of the present invention along the longitudinal direction.

Fig. 5 shows another example of a cross-sectional view of the distal end portion of the extension guide catheter according to the embodiment of the present invention along the longitudinal direction.

Fig. 6 shows another example of a cross-sectional view of the distal end portion of the extension guide catheter according to the embodiment of the present invention along the longitudinal direction.

Fig. 7 shows another example of a cross-sectional view of the distal end portion of the extension guide catheter according to the embodiment of the present invention along the longitudinal direction.

Fig. 8 shows another example of a cross-sectional view of the distal end portion of the extension guide catheter according to the embodiment of the present invention along the longitudinal direction.

Fig. 9 shows another example of a cross-sectional view of the distal end portion of the extension guide catheter according to the embodiment of the present invention along the longitudinal direction.

Fig. 10 shows another example of a cross-sectional view of the distal end portion of the extension guide catheter according to the embodiment of the present invention along the longitudinal direction.

Fig. 11 shows another example of a cross-sectional view of the distal end portion of the extension guide catheter according to the embodiment of the present invention along the longitudinal direction.

Fig. 12 shows another example of a cross-sectional view of a distal end portion of an elongate guiding catheter according to an embodiment of the present invention along the longitudinal direction.

Fig. 13 shows another example of a cross-sectional view of the distal end portion of the extension guide catheter according to the embodiment of the present invention along the longitudinal direction.

Detailed Description

The extension guide catheter of the present invention will be specifically described below based on the following embodiments, but the present invention is not limited to the following embodiments, and can be appropriately modified and implemented within the scope of the gist described above and below, and they are included in the technical scope of the present invention. In each drawing, hatching, component reference numerals, and the like may be omitted for convenience, but in this case, reference is made to the specification and other drawings. In addition, the dimensions of the various components in the drawings are preferred to facilitate an understanding of the features of the present invention, and thus there are cases where they are different from the actual dimensions.

An extension guide catheter according to an embodiment of the present invention will be described with reference to fig. 1 to 13. Fig. 1 is a view showing an entire extension guide catheter according to an embodiment of the present invention, fig. 2 is a view showing a state in which the extension guide catheter according to the embodiment of the present invention is inserted into a guide catheter disposed in a blood vessel and is extended and projected from an opening on a distal side of the guide catheter, and fig. 3 to 13 are examples of cross-sectional views along a longitudinal direction of a distal end portion of the extension guide catheter according to the embodiment of the present invention.

An extension guide catheter is used in combination with a guide catheter, specifically, inserted into the guide catheter and projected from an opening on the distal side of the guide catheter. By using the extension guide catheter, a treatment device such as an intravascular treatment device can be stably delivered to a distal end. Examples of the intravascular treatment device include a stent and a balloon.

As shown in fig. 1, an extension guide catheter 1 according to an embodiment of the present invention includes: a cylindrical body 2 having an inner cavity 3 extending in the longitudinal direction x; and a linear member 12 fixed to the tubular body 2 and extending proximally from the proximal opening 4 of the tubular body 2. The tubular body 2 has a proximal opening 4 and a distal opening 5. The proximal opening 4 of the tubular body 2 is an opening on the proximal side of the inner chamber 3 of the tubular body 2, and the distal opening 5 of the tubular body 2 is an opening on the distal side of the inner chamber 3 of the tubular body 2. In the tubular body 2, a portion including a distal end forming the distal opening 5 is referred to as a distal end 6 of the tubular body 2. Specifically, in the tubular body 2, a range in the longitudinal direction x from the distal end of the tubular body 2 to the proximal end of a groove portion described later is referred to as a distal end portion 6 of the tubular body 2.

As shown in fig. 2, the extension guide catheter 1 is first inserted into a guide catheter 21 disposed in a body cavity at the time of surgery and used. Specifically, the extension guide catheter 1 is inserted into the guide catheter 21 from the proximal opening of the guide catheter 21, and the extension guide catheter 1 is used by extending and protruding distally from the distal opening 22 of the guide catheter 21. Fig. 2 shows a state in which the extension guide catheter 1 is disposed in the guide catheter 21 disposed in the ascending aorta, and the extension guide catheter 1 extends and protrudes from the opening 22 on the distal side of the guide catheter 21.

The extension guide catheter 1 can advance or retract the tubular body 2 in the guide catheter 21 by pushing or pulling the linear member 12, can protrude from the opening 22 on the distal side of the guide catheter 21 to the distal side, or can be pulled back into the guide catheter 21. Further, by sending a treatment device such as an intravascular treatment instrument through the guide catheter 21 and the extension guide catheter 1, the treatment device can be brought to the more distal end in the body cavity. For retracting the elongate guiding catheter 1, the inner diameter of the guiding catheter 21 is larger than the outer diameter of the elongate guiding catheter 1. The treatment device can extend distally from the distal opening 5 of the tubular body 2 of the extension guide catheter 1 by entering the guide catheter 21 from the proximal opening of the guide catheter 21 and passing through the guide catheter 21, and further entering the extension guide catheter 1 from the proximal opening 4 of the extension guide catheter 1 and passing through the extension guide catheter 1.

In the extension guide catheter 1, the longitudinal direction x is determined as the extension direction of the extension guide catheter 1, specifically, the extension direction of the tubular body 2 and the linear member 12. The elongate guiding catheter 1 has a proximal side and a distal side as one side and the other side with respect to the long axis direction x. In the extension guide catheter 1, the proximal side is a direction on the side of the user's hand, i.e., the operator, with respect to the extension direction of the extension guide catheter 1, and the distal side is a direction opposite to the proximal side, i.e., the treatment target side. The cylindrical body 2 has a radial direction as an orthogonal direction to the long axis direction x. In fig. 1, the right side of the figure corresponds to the proximal side, and the left side of the figure corresponds to the distal side.

The length of the extension guide catheter 1 in the longitudinal direction x is, for example, preferably 800mm or more, more preferably 1000mm or more, further preferably 1200mm or more, further preferably 2200mm or less, further preferably 2000mm or less, further preferably 1800mm or less. The length of the tubular body 2 in the longitudinal direction x is, for example, preferably 100mm or more, more preferably 200mm or more, further preferably 250mm or more, further preferably 600mm or less, more preferably 500mm or less, further preferably 450mm or less.

The diameter of the lumen 3 of the tubular body 2 is preferably 1.0mm or more, more preferably 1.1mm or more, further preferably 1.3mm or more, still more preferably 2.2mm or less, further preferably 2.0mm or less, further preferably 1.9mm or less, from the viewpoint of securing the insertion property in the guide catheter of the extension guide catheter 1 and the insertion property of the treatment device in the extension guide catheter 1. The outer diameter of the tubular body 2 is preferably 1.2mm or more, more preferably 1.3mm or more, further preferably 1.4mm or more, further preferably 3.5mm or less, further preferably 3.0mm or less, further preferably 2.5mm or less. The wall thickness of the tubular body 2 is preferably 0.01mm or more, more preferably 0.02mm or more, further preferably 0.05mm or more, further preferably 0.4mm or less, more preferably 0.3mm or less, further preferably 0.2mm or less.

In the vertical cross section of the tubular body 2 with respect to the longitudinal axis direction x, the shape of the inner cavity 3 of the tubular body 2 and the shape of the outer edge of the tubular body 2 are not particularly limited, and examples thereof include a circle, an ellipse, an oblong, a polygon, an amorphous, and the like. When the shape of the inner cavity 3 of the tubular body 2 and the shape of the outer edge are other than circular, the diameter of the inner cavity 3 of the tubular body 2 and the outer diameter of the tubular body 2 described above refer to equivalent circular diameters. That is, the diameter of a circle having the same length as the circumference of the inner cavity 3 of the tubular body 2 or the circumference of the outer edge of the tubular body 2. The shape of the inner cavity 3 of the tubular body 2 and the shape of the outer edge of the tubular body 2 are preferably circular or elliptical, and in the case of an ellipse, the ratio of the minor diameter to the major diameter is preferably 0.80 or more, more preferably 0.90 or more, and still more preferably 0.95 or more.

The tubular body 2 is formed of, for example, a resin layer. Examples of the resin constituting the resin layer include polyamide resin, polyester resin, polyurethane resin, polyolefin resin, fluorine-based resin, vinyl chloride-based resin, silicone resin, and natural rubber. Examples of the polyamide resin include nylon 12, nylon 12 elastomer, nylon 6, and aromatic polyamide. Examples of the polyester resin include polyethylene terephthalate and the like. Examples of the urethane resin include aliphatic urethane containing an aliphatic isocyanate as a monomer unit and aromatic urethane containing an aromatic isocyanate as a monomer unit. Examples of the polyolefin resin include polyethylene and polypropylene. Examples of the fluorine-based resin include polytetrafluoroethylene, ethylene tetrafluoroethylene copolymer, fluorinated ethylene propylene copolymer, and the like. Examples of the vinyl chloride resin include polyvinyl chloride and polyvinylidene chloride. Examples of the silicone resin include dimethylpolysiloxane, methylphenylpolysiloxane, methylvinylpolysiloxane, and fluoroalkylmethylpolysiloxane. Examples of the natural rubber include latex.

The cylindrical body 2 may be formed of a single layer or a plurality of layers. In the longitudinal direction x, a part of the tubular body 2 may be formed of a single layer, and the other part may be formed of a plurality of layers.

The cylinder 2 preferably has a reinforcing layer. The rigidity of the tubular body 2 can be improved by the reinforcing layer. The reinforcing layer may be provided on the inner side surface of the tubular body 2, may be provided on the outer side surface, or may be provided between the inner side surface and the outer side surface of the tubular body 2.

The reinforcing layer can be composed of metal wires, fibers, or the like. Examples of the material constituting the metal wire include stainless steel, titanium, nickel-titanium alloy, cobalt-chromium alloy, and tungsten alloy. Among them, stainless steel is preferable. The metal wire may be a single wire or a stranded wire. Examples of the fibers include polyarylate fibers, aramid fibers, ultra-high molecular weight polyethylene fibers, and PBO (poly-p-phenylene benzobisonAzole) fibers, carbon fibers, and the like. The fibers may be monofilaments or multifilaments.

The shape of the reinforcing layer is not particularly limited, but is preferably spiral, mesh, or braid. Among them, the reinforcing layer is preferably woven from the point that the rigidity of the tubular body 2 can be effectively improved by the reinforcing layer.

The tubular body 2 may contain a radiation-impermeable substance so as to facilitate the confirmation of the position under X-ray fluoroscopy or the like. Examples of the radiation-impermeable substance include lead, barium, iodine, tungsten, gold, platinum, iridium, platinum iridium alloy, stainless steel, titanium, cobalt chromium alloy, palladium, tantalum, and the like. For example, it is preferable to provide a radio-opaque marker at the proximal end and distal end of the tubular body 2, so that the position of the tubular body 2 in the body cavity can be confirmed under X-ray.

The outer side surface of the cylindrical body 2 may be coated with a hydrophilic polymer. This makes it possible to easily insert the tubular body 2 into the guide catheter or the blood vessel. Examples of the hydrophilic polymer include hydrophilic polymers such as maleic anhydride copolymers, e.g., poly (2-hydroxyethyl methacrylate), polyacrylamide, polyvinylpyrrolidone, and methyl vinyl ether maleic anhydride copolymers.

The cartridge 2 preferably has an inner layer and an outer layer. The inner and outer layers can be composed of the resins described above. The inner layer is preferably composed of at least one selected from the group consisting of polyester resin, polyolefin resin, fluorine-based resin, silicone resin, and natural rubber. In particular, the inner layer is preferably made of a fluororesin, since the inner layer is excellent in chemical resistance, non-tackiness, and low friction. The outer layer is preferably made of at least one resin selected from the group consisting of polyamide resins, polyurethane resins, and polyolefin resins, more preferably made of at least one resin selected from the group consisting of polyamide resins and polyurethane resins, and still more preferably made of polyurethane resins.

The tubular body 2 preferably has a reinforcing layer in addition to the inner and outer layers. The reinforcing layer may be provided on the outer layer, or may be provided on the inner layer, or may be provided between the inner layer and the outer layer, but is preferably provided between the inner layer and the outer layer from a point where the strength of the tubular body 2 is easily improved.

The linear member 12 is a long wire and is fixed to the proximal end of the tubular body 2. The tubular body 2 can be advanced or retracted by pushing or pulling the linear member 12, whereby the tubular body 2 can be projected from the opening on the distal side of the guide catheter or the tubular body 2 can be pulled back into the guide catheter.

Preferably, the wire member 12 is made of metal. The metal constituting the linear member 12 may be, for example, stainless steel, titanium, nickel-titanium alloy, cobalt-chromium alloy, tungsten alloy, or the like, and among these, stainless steel is more preferable. The cross-sectional shape of the linear member 12 in the direction perpendicular to the longitudinal axis direction x is not particularly limited, and examples thereof include a square, a rectangle, a trapezoid, and other quadrangle, a polygon other than a quadrangle, a circle, an ellipse, and an oblong. Among them, the linear member 12 is preferably quadrangular in cross-sectional shape.

The elongate guiding catheter 1 is preferably provided with a grip member 13 at the proximal end of the linear member 12. The operator grips the grip member 13 with his or her fingers, and thus the operator can easily push or pull the extension guide catheter 1. The material constituting the holding member 13 may be a resin, and the resin may be a polyolefin resin such as polyethylene or polypropylene.

The linear member 12 may be fixed to the inner surface of the tubular body 2, may be fixed to the outer surface of the tubular body 2, or may be fixed between the inner surface and the outer surface of the tubular body 2. When the tubular body 2 has an inner layer and an outer layer, the linear member 12 may be fixed to the inner layer of the tubular body 2, may be fixed to the outer layer, or may be fixed between the inner layer and the outer layer. The linear member 12 is fixed to one side in the radial direction of the tubular body 2.

Further, although the extension guide catheter 1 is used by being inserted into a guide catheter or a body cavity, when the treatment device is sent out from the guide catheter through the extension guide catheter 1, if the extension guide catheter 1 is set at a desired position in the body cavity, the distal end 6 of the tubular body 2 may be located at a curved portion of the body cavity. In this case, the distal end 6 of the tubular body 2 is bent along the bent portion of the body cavity, but in the portion where the body cavity is greatly bent, a kink occurs in the distal end 6 of the tubular body 2, and as a result, there is a concern that the cross-sectional shape of the lumen 3 of the tubular body 2 is deformed at the distal end 6, and the size of the lumen 3 is narrowed.

Therefore, in the extension guide catheter 1 according to the embodiment of the present invention, as shown in fig. 3, an annular or spiral groove 7 extending in the circumferential direction is provided on the inner side surface of the distal end 6 of the tubular body 2, and the thickness of the tubular body 2 is formed to be thin at the portion where the groove 7 is provided. Fig. 3 shows an example of a cross-sectional view of the distal end 6 of the extension guide catheter shown in fig. 1 along the longitudinal direction x, and shows an example in which an annular groove 7 extending in the circumferential direction is provided on the inner side surface of the distal end 6 of the tubular body 2. By forming the distal end 6 of the tubular body 2 in this manner, the distal end 6 of the extension guide catheter 1 can be easily bent, and the extension guide catheter 1 can be easily moved smoothly in the guide catheter and the body cavity. Further, even if the distal end 6 of the tubular body 2 is located at the curved portion of the body cavity, kinking such that the lumen 3 is crushed is less likely to occur at the distal end 6 of the tubular body 2, and the cross-sectional shape of the lumen 3 can be suppressed from being greatly deformed at this portion. Therefore, it is easy to extend and protrude a treatment device such as an intravascular treatment device from the distal opening 5 through the distal end 6 of the tubular body 2. Further, by providing the groove 7 on the inner side surface of the distal end 6 of the tubular body 2, the inner surface of the lumen 3 is less likely to bulge when bending, and the lumen 3 can be suppressed from narrowing. Therefore, it is easy to make the treatment device extend and protrude from the distal opening 5 through the distal end 6 of the tubular body 2.

The distal end 6 of the tubular body 2 has a portion provided with the groove 7 and a portion where the groove 7 is not provided, and the wall thickness of the tubular body 2 at the portion provided with the groove 7 is formed thinner than the wall thickness of the tubular body 2 at the portion adjacent to the groove 7 where the groove 7 is not provided, as viewed from the inner side. Accordingly, the groove portion 7 is formed as a bottomed groove. The inner surface of the distal end 6 of the tubular body 2 is preferably formed flat at a portion where the groove 7 is not provided, and is preferably formed to be recessed from a portion where the groove 7 is not provided.

The groove 7 is preferably formed within 10mm from the distal end of the tubular body 2 toward the proximal side. Specifically, the proximal end of the groove 7 is preferably located within 10mm, more preferably within 9mm, and even more preferably within 8mm from the distal end of the tubular body 2 to the proximal side. Therefore, the length of the distal end portion 6 of the tubular body 2 in the longitudinal direction x is preferably 10mm or less, more preferably 9mm or less, and even more preferably 8mm or less. On the other hand, the proximal end of the groove 7 is preferably located at a position separated by 1mm or more from the distal end of the tubular body 2 toward the proximal side, more preferably at a position separated by 1.5mm or more, and even more preferably at a position separated by 2mm or more. Therefore, the length of the distal end portion 6 of the tubular body 2 in the longitudinal direction x is preferably 1mm or more, more preferably 1.5mm or more, and even more preferably 2mm or more.

The width of the groove 7, that is, the length of the groove 7 in the longitudinal direction x of the tubular body 2 is preferably 0.5mm or more, more preferably 0.8mm or more, and further preferably 3.0mm or less, more preferably 2.5mm or less. The depth of the groove 7 is preferably 0.1 times or more, more preferably 0.2 times or more, still more preferably 0.8 times or less, and still more preferably 0.7 times or less the wall thickness of the tubular body 2. If the groove 7 is formed in this manner, even if the distal end 6 of the tubular body 2 is located in the bent portion of the body cavity, the distal end 6 of the tubular body 2 is less likely to kink, and the distal end 6 of the tubular body 2 is more likely to bend smoothly. The wall thickness of the tubular body 2 described here refers to the wall thickness of the tubular body 2 at a portion adjacent to the groove 7 where the groove 7 is not provided, and refers to the average value of the wall thickness of the tubular body 2 at a portion adjacent to the groove 7 on the far side and the wall thickness of the tubular body 2 at a portion adjacent to the near side.

The cross-sectional shape of the groove 7, that is, the cross-sectional shape of the groove 7 when the distal end 6 of the tubular body 2 is cut along the longitudinal direction x as shown in fig. 3, is not particularly limited. Although fig. 3 shows an example of the groove 7 having an arc-shaped cross section, the groove 7 may have a V-shaped cross section as shown in fig. 4, for example. The cross-sectional shape of the groove 7 may be a U-shape, a shape in which one side of a polygon is cut (for example, a shape in which one side of a rectangle is cut), or the like. As shown in fig. 5, the groove 7 may have an arc shape formed by a part of an ellipse.

In a cross section of the distal end 6 of the tubular body 2 along the longitudinal direction x, an angle formed between a proximal wall surface of the groove 7 and the longitudinal direction x may be the same or different from an angle formed between a distal wall surface of the groove 7 and the longitudinal direction x. Here, the angle formed by the proximal or distal wall surface of the groove 7 and the longitudinal direction x is a range exceeding 0 ° and 90 ° or less in the angle difference between the longitudinal direction x and the proximal or distal wall surface of the groove 7 in the cross section of the distal end 6 of the tubular body 2 along the longitudinal direction x. When the wall surface of the groove 7 is curved in a cross section along the long axis direction x, the extending direction of the wall surface of the groove 7 is the extending direction of the tangential line of the wall surface, and the angle between the wall surface of the groove 7 and the long axis direction x is the angle at which the greatest angle difference is obtained from the long axis direction x.

For example, as shown in fig. 3, the angle between the wall surface on the proximal side of the groove 7 and the long axis direction x may be the same as the angle between the wall surface on the distal side of the groove 7 and the long axis direction x, as shown in fig. 4, the angle between the wall surface on the proximal side of the groove 7 and the long axis direction x may be larger than the angle between the wall surface on the distal side of the groove 7 and the long axis direction x, and conversely, as shown in fig. 5, the angle between the wall surface on the proximal side of the groove 7 and the long axis direction x may be smaller than the angle between the wall surface on the distal side of the groove 7 and the long axis direction x. As shown in fig. 4 and 5, if the angle between the wall surface on the proximal side of the groove 7 and the longitudinal direction x is different from the angle between the wall surface on the distal side of the groove 7 and the longitudinal direction x, even if the distal end 6 of the tubular body 2 is bent at a larger angle, the tubular body can be easily and smoothly bent, and the width of the groove 7 can be ensured, so that the occurrence of kinks at the time of bending the distal end 6 of the tubular body 2 can be more easily suppressed.

When the groove 7 is formed in a ring shape extending in the circumferential direction, the number of the ring-shaped groove 7 formed in the distal end 6 of the tubular body 2 may be 1 or 2 or more. On the other hand, the upper limit of the number of annular grooves 7 formed in the distal end portion 6 of the tubular body 2 is preferably 8 or less, more preferably 6 or less, and even more preferably 4 or less. When the plurality of annular grooves 7 are provided, the plurality of annular grooves 7 may have the same width or different widths, and the plurality of annular grooves 7 may have the same depth or different depths. Preferably, each annular groove 7 is formed to continuously surround the tubular body 2 in the circumferential direction.

Fig. 6 to 8 show examples in which a plurality of annular grooves 7 are provided in the distal end 6 of the tubular body 2. In fig. 6, 3 grooves 7 of the same size are arranged in the longitudinal direction x at the distal end 6 of the tubular body 2. In fig. 7,3 grooves 7 are arranged in the longitudinal direction x at the distal end 6 of the tubular body 2 so that the size of the groove 7 on the proximal side is larger than the size of the groove 7 on the distal side. In fig. 8, 3 grooves 7 are arranged in the longitudinal direction x at the distal end 6 of the tubular body 2 so that the size of the groove 7 on the distal side is larger than the size of the groove 7 on the proximal side. If a plurality of annular grooves 7 are provided in the distal end 6 of the tubular body 2 in this manner, the distal end 6 of the tubular body 2 can be more easily bent. Further, by adjusting the size of each groove 7 arranged in the longitudinal direction x, the bending mode of the distal end 6 of the tubular body 2 can be arbitrarily set.

When the groove 7 is formed in a spiral shape, the spiral groove 7 is preferably formed to be wound at least once in the circumferential direction of the tubular body 2. The upper limit of the number of windings of the spiral groove 7 is preferably 8 weeks or less, more preferably 6 weeks or less, and even more preferably 4 weeks or less. Further, from the viewpoint of easily ensuring isotropy of the bending of the distal end portion 6 of the tubular body 2, the groove portion 7 is preferably provided in a ring shape extending in the circumferential direction.

The distal end 6 of the tubular body 2 is preferably formed flat in the outer side within the range of the longitudinal direction x in which the groove 7 is provided. That is, the outer surface of the distal end 6 of the tubular body 2 is preferably different from the inner surface of the distal end 6 of the tubular body 2, and no irregularities such as the groove 7 are formed. When the distal end 6 of the tubular body 2 is formed in this manner, the distal end 6 of the tubular body 2 does not catch on the inner wall of the guide catheter or the body cavity when the extension guide catheter 1 is advanced in the guide catheter or the body cavity, and the extension guide catheter 1 can easily advance smoothly in the guide catheter or the body cavity.

The outer surface of the distal end portion 6 formed in a flat shape may be formed parallel to the longitudinal direction x or may be formed inclined to the longitudinal direction x in a cross section along the longitudinal direction x. For example, as shown in fig. 9 to 11, the outer surface of the distal end 6 of the tubular body 2 may have an inclined portion 8 inclined toward the long axis side of the tubular body 2 (i.e., toward the central axis side of the tubular body 2). Fig. 9 to 11 show examples in which the inclined portion 8 is formed on the outer surface of the distal end portion 6 of the tubular body 2 in addition to the embodiment shown in fig. 6, and the configuration of the groove portion 7 can be arbitrarily changed. As described above, if the inclined portion 8 is formed on the outer surface of the distal end portion 6 of the tubular body 2, the distal end portion 6 of the tubular body 2 can easily smoothly travel in the guide catheter or the body cavity. In addition, the distal end 6 of the tubular body 2 is easily bent and advanced smoothly at the bending portion of the guide catheter and the body cavity. The inclined portion 8 may be formed only in a part of the distal end portion 6 of the tubular body 2, or may be formed in the whole. The inclined portion 8 may extend from the distal end 6 to the proximal side of the distal end 6. Further, the outer surface of the distal end 6 of the tubular body 2 preferably does not have a portion inclined toward the longitudinal axis side of the proximal tubular body 2.

In one embodiment, as shown in fig. 9, the distal end 6 of the tubular body 2 has a first section 9 including the distal end of the tubular body 2 and a second section 10 located closer to the distal end than the first section, with respect to the longitudinal direction x, and the outer surface of the distal end 6 of the tubular body 2 can be formed parallel to the longitudinal direction x in the second section 10 and inclined toward the longitudinal side of the tubular body 2 in the first section 9. When the distal end 6 of the tubular body 2 is formed in this manner, the distal end 6 of the tubular body 2 can smoothly travel in the guide catheter and the body cavity, and the distal end 6 of the tubular body 2 can smoothly bend and travel in the curved portion of the guide catheter and the body cavity.

In other embodiments, as shown in fig. 10, the distal end 6 of the tubular body 2 has a first section 9 including the distal end of the tubular body 2 and a second section 10 located closer to the distal end than the first section, and the outer surface of the distal end 6 of the tubular body 2 is formed to be inclined toward the long axis side of the tubular body 2 in the second section 10, and the first section 9 may be formed to be inclined toward the long axis side of the tubular body 2 in the distal side so that the angle between the outer surface and the long axis direction x is larger than the angle between the outer surface and the long axis direction x in the second section 10. Even if the distal end 6 of the tubular body 2 is formed in this way, the distal end 6 of the tubular body 2 can smoothly travel in the guide catheter and the body cavity, and the distal end 6 of the tubular body 2 can smoothly bend and travel in the curved portion of the guide catheter and the body cavity.

When the first section 9 and the second section 10 are provided at the distal end 6 of the tubular body 2, the first section 9 including the distal end of the tubular body 2 may be formed such that the angle formed by the outer surface and the longitudinal direction x becomes gradually or continuously larger toward the distal side. Fig. 11 shows an example in which the distal end 6 of the tubular body 2 is formed in this way. In fig. 11, the first section 9 of the distal end 6 of the tubular body 2 is formed such that the angle between the outer surface and the longitudinal direction x continuously increases toward the distal side. Specifically, in a cross section of the distal end portion 6 of the tubular body 2 along the longitudinal direction x, an angle formed by a tangent line to the outer surface of the first section 9 of the distal end portion 6 of the tubular body 2 and the longitudinal direction x is continuously increased toward the distal side. If the first section 9 is formed as shown in fig. 11, the outer surface of the distal end of the tubular body 2 is formed in a cross section R-shape, that is, in a cross section along the longitudinal axis direction x of the distal end portion 6 of the tubular body 2, the outer surface of the distal end of the tubular body 2 is formed into a rounded shape, so that the distal end portion 6 of the tubular body 2 easily travels smoothly in the guide catheter or the body cavity. When the first section 9 of the distal end portion 6 of the tubular body 2 is formed such that the angle between the outer surface and the longitudinal direction x is gradually increased toward the distal side, the outer surface of the distal end of the tubular body 2 is chamfered, and therefore the distal end portion 6 of the tubular body 2 can smoothly travel in the guide catheter or the body cavity.

When the first section 9 and the second section 10 are provided at the distal end 6 of the tubular body 2, the groove 7 is preferably provided in the second section 10. Thus, a deeper groove can be formed in the distal end 6 of the tubular body 2, and the distal end 6 of the tubular body 2 can be easily bent smoothly at the portion where the groove 7 is provided in the bending portion of the guide catheter or the body cavity. Therefore, even if the distal end 6 of the tubular body 2 is located in the curved portion of the body cavity, kinks are less likely to occur in the distal end 6 of the tubular body 2. In this case, the groove 7 may not be provided in the first section 9.

The distal end 6 of the tubular body 2 is preferably formed of a resin layer. This facilitates the formation of the groove 7 on the inner side surface of the distal end 6 of the tubular body 2. Further, the distal end 6 of the tubular body 2 is easily bent at the bending portion of the guide catheter or the body cavity while ensuring the bending property. The description of the resin layer of the distal end 6 of the tubular body 2 refers to the description of the resin layer of the tubular body 2 described above. The portion of the tubular body 2 on the position side of the groove 7 may be formed of a resin layer.

As shown in fig. 12, the distal end portion 6 of the tubular body 2 may be configured to have an inner layer 6A and an outer layer 6B. In this case, the inner layer 6A is preferably made of a material having higher rigidity than the outer layer 6B, and the groove 7 is formed at least in the inner layer 6A. If the distal end 6 of the tubular body 2 is configured in this manner, kinking is less likely to occur in the distal end 6 of the tubular body 2, and flexibility of the distal end 6 of the tubular body 2 is more likely to be ensured. The inner layer 6A is preferably composed of at least one selected from the group consisting of polyester resin, polyolefin resin, fluorine-based resin, silicone resin, natural rubber, polyamide resin, and polyurethane resin, for example. The outer layer 6B is preferably made of at least one resin selected from the group consisting of polyamide resins, polyurethane resins, and polyolefin resins, more preferably at least one resin selected from the group consisting of polyamide resins and polyurethane resins, and still more preferably polyurethane resins.

As shown in fig. 12 and 13, the tubular body 2 preferably has a high rigidity portion 11 on the position side of the distal end portion 6 with respect to the longitudinal direction x, and the high rigidity portion 11 is made of a material having higher rigidity than the distal end portion 6. If the tubular body 2 is configured in this manner, the tubular body 2 can easily smoothly travel in the curved portion of the guide catheter or the body cavity. Fig. 12 and 13 show examples in which the distal end 6 of the tubular body 2 has an inner layer 6A and an outer layer 6B and the high rigidity portion 11 is formed on the position side of the distal end 6 in the embodiment shown in fig. 6, but the configuration of the groove portion 7 and the configuration of the outer surface of the tubular body 2 can be arbitrarily changed.

As shown in fig. 13, the high rigidity portion 11 is preferably composed of a resin layer 11A and a reinforcing layer 11B in a spiral, mesh or braid shape. The reinforcing layer 11B can be formed by arranging metal wires or fibers in a spiral, mesh or braid. By providing the reinforcing layer 11B in the high-rigidity portion 11 in this way, the inner cavity 3 of the tubular body 2 is less likely to collapse and less likely to kink in the high-rigidity portion 11. In addition, it is easy to insert the treatment device into the inner cavity 3 of the tubular body 2. The resin layer 11A of the high rigidity portion 11 may be made of the same resin as the resin layer of the distal end portion 6 of the tubular body 2 or may be made of a different resin. The resin layer 11A of the high-rigidity portion 11 may be formed to have an inner layer and an outer layer.

When the high rigidity portion 11 is provided in the tubular body 2, the distal end of the high rigidity portion 11 is preferably located within 15mm, more preferably within 12mm, and even more preferably within 10mm from the distal end of the tubular body 2 to the proximal side. As described above, the high rigidity portion 11 is provided at a position closer to the distal end portion 6 where the groove portion 7 is provided. The proximal end of the high rigidity portion 11 is preferably located within 15mm, more preferably within 12mm, and even more preferably within 10mm from the proximal end of the portion of the tubular body 2 formed into a tubular shape.

In the tubular body 2, it is preferable that a reinforcing layer is not provided at the distal end 6 provided with the groove 7. This ensures flexibility of the distal end 6 of the tubular body 2, and improves flexibility of the curved portion of the guide catheter or the body cavity.

The present application claims the benefit of priority based on japanese patent application No. 2021-169117, filed on 10 months 14 of 2021. The entire contents of the specification of Japanese patent application No. 2021-169117, filed on 10/14/2021, are incorporated herein by reference.

Description of the reference numerals

1 … Elongate guide catheter; 2 … cylinders; 3 … lumen; 4 … proximal openings; 5 … distal side openings; 6 … distal ends; A6A … inner layer; 6B … outer layer; 7 … slots; 8 … inclined portions; 9 … first intervals; 10 … second interval; 11 … high-rigidity portions; 11A … resin layer; 11B … reinforcement; 12 … linear parts; 13 … holding parts; 21 … guide the catheter.

Claims

1. An extension guide catheter for a guide catheter, comprising:

A tubular body having an inner cavity extending in a longitudinal direction and having a proximal opening and a distal opening; and

A linear member fixed to the tubular body and extending from a proximal opening of the tubular body to a proximal side,

An annular or spiral groove portion extending in the circumferential direction is provided on the inner side surface of the distal end portion of the cylindrical body, and the wall thickness of the cylindrical body is formed thin at the portion where the groove portion is provided.

2. The elongate guiding catheter of claim 1 wherein,

The outer surface of the distal end of the cylindrical body is formed flat in the longitudinal direction in which the groove is provided.

3. The elongate guiding catheter of claim 1 wherein,

The outer surface of the distal end of the tubular body has an inclined portion that is inclined toward the distal side toward the long axis of the tubular body.

4. The elongate guiding catheter of claim 1 wherein,

The distal end of the tubular body has a first section including a distal end of the tubular body and a second section closer to the distal end than the first section in the longitudinal direction,

An outer surface of a distal end of the tubular body is formed parallel to a longitudinal direction in the second section, and is formed inclined toward a distal side toward the longitudinal side of the tubular body in the first section.

5. The elongate guiding catheter of claim 1 wherein,

An outer surface of a distal end portion of the tubular body is formed to be inclined toward a distal side toward a long axis side of the tubular body in the second section, and is formed to be inclined toward the distal side toward the long axis side of the tubular body in the first section such that an angle formed between the outer surface and the long axis direction is larger than an angle formed between the outer surface and the long axis direction in the second section.

6. The elongate guiding catheter according to claim 4 or 5, wherein,

In the first section, an angle formed between the outer surface and the longitudinal direction increases stepwise or continuously toward the distal side.

7. The elongate guiding catheter according to claim 4 or 5, wherein,

The groove part is arranged in the second section.

8. The elongate guiding catheter of claim 1 wherein,

The cylindrical body has a high-rigidity portion on a position side with respect to the longitudinal direction with respect to the distal end portion, and the high-rigidity portion is made of a material having a higher rigidity than the distal end portion.

9. The elongate guiding catheter of claim 8 wherein,

The distal end portion is formed of a resin layer, and the high-rigidity portion is formed of a resin layer and a spiral, mesh or braid reinforcing layer.

10. The elongate guiding catheter of claim 1 wherein,

The distal end portion has an inner layer and an outer layer, the inner layer is made of a material having higher rigidity than the outer layer, and the groove portion is formed at least in the inner layer.

11. The elongate guiding catheter of claim 1 wherein,

The length of the distal end in the longitudinal direction is 1mm or more and 10mm or less.